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Billable Products User Fee Billable Products Approved Under Section 351 of the PHS Act   PDUFA Guidances / Rules   Performance Reports PDUFA III - FY 2002 Performance Report to Congress for the Prescription Drug User Fee Act of 1992 PDUFA II - FY 2001 Performance Report to Congress for the Prescription Drug User Fee Act of 1992 FY 2000 Performance Report to Congress for the Prescription Drug User Fee Act of 1992 FY 1999 Performance Report to Congress for the Prescription Drug User Fee Act of 1992 FY 1998 Performance Report to Congress - (Text), (PDF) PDUFA I - Final Performance Report (FY 1997) Fourth Annual Performance Report (FY 1996) Third Annual Performance Report (FY 1995)   PDUFA III PDUFA III Five-Year Plan - July, 2003 FEDERAL REGISTER Prescription Drug User Fee Act III Five-Year Plan; Availability - 10/14/2003 - (PDF), (Text) PDUFA Reauthorization Performance Goals and Procedures Prescription Drug User Fee Amendments of 2002 PDUFA III Letter - Tommy Thompson - 6/4/2002 - (Text)   PDUFA II PDUFA II Meeting 2000: Consulting with Stakeholders - 9/15/2000 PDUFA II Five-Year Plan - July, 1998 PDUFA II Five-Year Plan - FY 1999 Revision - July 1999 - Describes plans to achieve the new goals associated the the Prescription Drug User Fee Act of 1992 (PDUFA), as amended and extended through the year 2002 by the Food and Drug Modernization Act of 1997. PDUFA II Five-Year Plan - FY 2000 Update - July 2000 - Provides background information on PDUFA and a summary of the PDUFA II goals, and discusses the 10 major assumptions on which the plan is based and how those assumptions have changed since the original plan was issued in 1998. PDUFA II Letter - Donna Shalala - 11/12/1997 - (Text) PDUFA II Reauthorization Performance Goals and Procedures - 11/12/1997 - (Text) - (PDF)   User Fee Rates FEDERAL REGISTER Establishment of Prescription Drug User Fee Rates Fiscal Year 2005 - 8/2/2004 - (PDF), (Text) Fiscal Year 2004 - 8/1/2003 - (PDF), (Text) Fiscal Year 2003 - 8/2/2002 - (PDF), (Text) Fiscal Year 2002 - 1/16/2002 - (PDF), (Text) Fiscal Year 2001 - 12/18/2000 - (PDF), (Text) Fiscal Year 2000 - 12/28/1999 - (PDF), (Text) Fiscal Year 1999 - 12/22/1998 - (PDF) (Text) Fiscal Year 1998 - 12/9/1997 - (PDF), (Text)

Updated October 27, 2004

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